The two sessions of the National People’s Congress and the National People’s Congress are about to be held, and the deputies and members have made suggestions one after another.
On March 2, the reporter of “daily economic news” learned that as a deputy to the 13th National People’s Congress, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) President Chen Baohua will bring six suggestions and motions this year, focusing on the digital economy, elderly care services, new drug imitation and other directions.
Since the 18th CPC National Congress, in order to promote the high-quality development of China Meheco Group Co.Ltd(600056) industry and accelerate China’s leap from a large pharmaceutical country to a powerful pharmaceutical country, the CPC Central Committee and the State Council have adhered to the people-centered development concept and the principle of paying equal attention to innovation and imitation, and issued a series of policy opinions to encourage the creation of new drugs and the research and development of generic drugs. The State Food and drug administration has conscientiously implemented the decisions and arrangements of the central government, timely revised and implemented the measures for the administration of drug registration (effective from July 1, 2020) and relevant policies and measures, continued to promote the reform of the drug registration and approval system, and accelerated the listing of new drugs and generic drugs to benefit the country and the people.
“However, judging from the urgent needs of the Chinese people for safe, effective and accessible drugs, the actual development of the pharmaceutical industry, and the practices of advanced countries and regions in the world, there are still some unreasonable historical problems in China’s current drug management policies, which need to be revised and improved.” Based on the perspective of China’s new drug imitation policy, Chen Baohua pointed out that “at present, there is a problem that China’s class 1 innovative drugs and class 2 improved new drugs can not be imitated, which has become the focus of the majority of pharmaceutical enterprises and affects the accessibility of people’s demand for drugs.”
According to the current requirements for registration classification and application data of chemical drugs, “class 1” of China National Chemical Engineering Co.Ltd(601117) drugs is an innovative drug that is not listed at home and abroad, which refers to “drugs with new structures, pharmacological compounds and clinical value” “Category 2” refers to the improved new drugs that are not listed at home and abroad. It refers to the drugs that “optimize their structure, dosage form, prescription process, administration route and indications on the basis of known active ingredients, and have obvious clinical advantages.”
A batch of new drugs emerged at the end of the 20th century and provided an important guarantee for the rapid development of China’s drug industry. With the gradual improvement of the norms of the pharmaceutical industry and based on the national conditions, the people have a wide and urgent demand for Chinese new drugs that have been proved safe and effective.
However, the reality is that Chinese new drugs cannot be imitated due to the constraints of current policies. There is a phenomenon that one company monopolizes the market for a long time after listing (even if the patent protection period of new drugs has long expired), forming a monopoly price sales. Chen Baohua believes that this is not only contrary to the purpose of medical reform, such as improving drug accessibility, reducing the burden of drug use and national medical insurance expenses, but also inconsistent with the principle of drug examination system reform, which encourages innovation and imitation.
The reason why Chinese new drugs can not be imitated is that Chinese new drugs have no status as reference preparations, both in policy and in practice. Without reference preparations, it is impossible to study the consistency of quality and efficacy, and pharmaceutical enterprises cannot copy Chinese new drugs.
In this regard, Chen Baohua suggested that we should speed up the revision and improvement of the current relevant policies, endow China with the status of reference preparation of new drugs, create preconditions for the imitation of Chinese new drugs, and encourage the listing of generic drugs. On the specific improvement path, Chen Baohua suggested that China’s new drug imitation policy should be improved from two aspects: first, China’s class 1 innovative drugs that have been approved for listing and China’s class 2 improved drugs that have clinical value / advantages, safety and effectiveness should be directly given the status of reference agent. Second, the national drug regulatory department will organize a comprehensive review and evaluation of China’s class 2 improved new drugs that have been approved for listing but whose clinical advantages are not clear.
